Prednisone Oral Solution

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Roxane Laboratories, Inc (2015-05-29)
Oldest Current Product
1984-11-08
License(s)
ANDA
RxNORM
ORAL SOLUTION\PREDNISONE
FDAOB
ORAL\SOLUTION\PREDNISONE
SPL Active
ORAL\SOLUTION, CONCENTRATE\PREDNISONE
ORAL\SOLUTION\PREDNISONE
SPL Moiety
ORAL\SOLUTION, CONCENTRATE\PREDNISONE
ORAL\SOLUTION\PREDNISONE

product(s) by strength(s)

prednisone 5 mg/ml oral solution

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000543721ANDARoxane Laboratories, Inc1985-02-20PREDNISONEORALSOLUTION, CONCENTRATEANDA0888103115aef0-fd50-4ec8-a064-3effb695f3f2
2000543722ANDARoxane Laboratories, Inc1986-12-13PREDNISONEORALSOLUTIONANDA0887033115aef0-fd50-4ec8-a064-3effb695f3f2
3000548722ANDARoxane Laboratories, Inc1984-11-08PREDNISONEORALSOLUTIONANDA0887033115aef0-fd50-4ec8-a064-3effb695f3f2

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA088703PREDNISONEROXANE LABORATORIES INC1984-11-08ANDA088703_001
2ANDA088810PREDNISONE INTENSOLROXANE LABORATORIES INC1985-02-20ANDA088810_001
3ANDA089726PREDNISONETrueWOCKHARDT EU OPERATIONS (SWISS) AG1988-08-02ANDA089726_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1ANDA088703_001RXPREDNISONE (5MG/5ML)ORALSOLUTIONTrue1984-11-08PREDNISONE
2ANDA088810_001RXPREDNISONE (5MG/ML)ORALSOLUTIONTrue1985-02-20PREDNISONE INTENSOL
3ANDA089726_001discontinuedPREDNISONE (5MG/5ML)ORALSOLUTIONFalse1988-08-02PREDNISONE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
13115aef0-fd50-4ec8-a064-3effb695f3f2 (view SPL)PredniSONE Tablets USP, 1 mg, 2.5 mg, 5 mg, 10 mg, 20 mg, and 50 mg, PredniSONE Oral Solution USP, 5 mg per 5 mL and PredniSONE Intensol Oral Solution (Concentrate), 5 mg per mLprescriptionHuman PrescriptionRoxane Laboratories, IncMANUFACTURE2015-05-297000543721, 000543722, 000548722, 000540017, 000540018, 000540019, 000544728, 000544741, 000544742, 000548724, 000548739, 000548740Prednisone Oral Tablet

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII